The Center for Drug Evaluation (CDE) website has indicated that China-based Thederma’s TAP-1503 cream is poised to receive priority review status for the local topical treatment of atopic dermatitis (AD) in patients aged two years and above. This priority status is granted due to the drug’s classification under “new varieties, dosage forms, and specifications of pediatric drugs that conform to children’s physiological characteristics.”
TAP-1503 is a small molecule chemical drug that contains 1% tapinarof, a Category psoriasis drug originally developed by Guanhao Biotech and approved for marketing in China in May 2019. Tapinarof made history in the United States when it was approved in May 2022, marking the first topical new molecular entity drug for the treatment of psoriasis in the US in 25 years. It is also the first and only non-steroidal topical drug of its kind to have received FDA approval.- Flcube.com
